Assessing the Pharmacokinetics, Safety, Tolerability and Efficacy of Continuous Oral Levodopa via the DopaFuse Delivery System in Parkinson’s Disease Patients - Study of Continuous Oral Levodopa: SCO

SynAgile Corporation0 sites24 target enrollmentJune 9, 2021

Overview

No summary available.

Registry

who.int

Start Date

June 9, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Diagnosis of Parkinson’s Disease consistent with UK Brain Bank Criteria
•2\. Age at least 30 years old at time of consent
•3\. Male and Female participants (Women of child\-bearing potential (WOCB) are eligible for participation if they are not pregnant or breastfeeding and agree to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 30 days after the last dose of study treatment)
•4\. Suitable for oral retainer wear
•5\. A good response to Levodopa, as assessed by the Investigator
•6\. At least 2 hours of wearing OFF time per day, as reported by the participant
•7\. Predictable early morning OFF periods, in the judgement of the participant and the Investigator
•8\. Taking 400\-1,200 mg of Levodopa/Carbidopa or Levodopa/Benserazide (LD/BZD) per day in at least 4 doses, with stable dosing for the last 28 days prior to screening. (Participants will be required to switch from LD/BZD to LD/CD no later than the morning of Day 1/Baseline (visit 4\).)
•9\. A modified Hoehn and Yahr of ? 3 in the ON state at screening
•10\. A stable regimen of anti\-PD medications for the last 28 days prior to Screening

•1\. Atypical or secondary Parkinson’s Disease
•2\. Severe Dyskinesia that might interfere with study performance in the judgement of Investigator
•3\. Clinically significant dysphagia or sialorrhea that might interfere with administration of study intervention in the judgement of the Investigator
•4\. Use of extended release levodopa within 28 days prior to screening
•5\. Any clinically significant medical, surgical, or psychiatric condition; laboratory value or ECG result which, in the opinion of the Investigator, makes the participant unsuitable for study entry or potentially unable to complete all aspects of the study.
•6\. Presence of clinically significant orthostatic hypotension at screening, in the opinion of Investigator or the EAC
•7\. Suicidal ideation within 1 year prior to the Screening Visit as evidenced by answering yes to Questions 4 or 5 on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale (C\-SSRS) or attempted suicide within the last 5 years.
•8\. History of psychosis or hallucinations in the past six months
•9\. Any malignancy in the past 5 years (excluding basal cell carcinoma of the skin or cervical carcinoma in situ that have been successfully treated.)
•10\. Current or previous diagnosis of malignant melanoma or the presence of any suspicious skin lesion based on physical exam findings